Director, Facilities & Environmental, Health & Safety - Pleasanton, CA

Summary:  

The Director, Facilities & EHS is responsible for strategic leadership and oversight of all facilities operations, maintenance programs, and site‑level environmental and safety compliance to ensure a safe, reliable, and audit‑ready environment for the manufacturing of urological medical devices. In addition this role requires strong EHS experience and full ownership of site Environmental, Health, and Safety programs. This leader ensures a compliant and efficient environment supporting sterile and non‑sterile manufacturing in a highly regulated setting. 

In This Role, You Will: 

Facilities Leadership & Site Operations 

• Oversee all facilities operations, including building systems (HVAC, compressed air, utilities, water systems), preventive maintenance, and vendor management. 
• Ensure reliable operation of critical environments such as cleanrooms, controlled manufacturing areas, metrology spaces, and laboratories. 
• Lead facilities planning, budgeting, and execution of capital improvement projects, including expansions, equipment installations, and infrastructure upgrades. 
• Maintain facility readiness for audits, inspections, and certifications (OSHA, FDA, ISO 13485, notified bodies, state and local agencies, customers). 
• Manage security, access control, janitorial, and site services. 
• Manage pest control program for all facilities per quality procedures. 

Environmental, Health and Safety 

• Maintain compliance with environmental regulations related to chemical storage, hazardous waste, wastewater, and air emissions. 
• Oversee waste streams common in urology device manufacturing (e.g., IPA, polymers, lubricants, sterilization residues, packaging materials). 
• Manage hazardous waste vendors, manifests, and reporting. 
• Lead sustainability initiatives focused on reducing waste from sterile packaging, plastics, and energy‑intensive processes. 
• Develop and maintain EHS policies, procedures, and training tailored to manufacturing of urology devices (catheters, scopes, disposables, electromechanical systems). 
• Conduct risk assessments, job hazard analyses, and ergonomic evaluations for assembly, cleanroom operations, and equipment handling. 
• Lead incident investigations and drive corrective/preventive actions. 
• Oversee industrial hygiene programs, including exposure monitoring for chemicals, adhesives, sterilants, and particulates. 
• Manage emergency response programs, including spill response and medical emergencies. 

Medical Device & Urology‑Specific Responsibilities 

• Ensure facilities and EHS programs align with FDA, ISO 13485, and GMP requirements for sterile and non‑sterile urology products. 
• Support safe handling of materials commonly used in urology device manufacturing (e.g., IPA, silicone, hydrophilic coatings, lubricants, adhesives, biocompatible polymers). 
• Partner with R&D and Quality to assess facility and EHS impacts of new product introductions, including device coatings, sterilization methods, and electromechanical components. 
• Support audits and inspections from FDA, notified bodies, and customers. 
• Contribute to risk management activities where EHS intersects with product safety, including ISO 14971 considerations. 

Leadership & Collaboration 

• Serve as the site’s subject‑matter expert for facilities and EHS. 
• Provide coaching and training to employees, supervisors, and cross‑functional teams; lead safety committees and drive a culture of accountability and continuous improvement. 
• Develop and maintain facilities and EHS metrics, dashboards, and reporting for leadership. 
• Manage budgets, consultants, and external service providers. 

Who You Will Report To: 

•  Vice President, People 

Requirements: 

• Education: Bachelor’s degree in Engineering, Facilities Management, Environmental Science, Occupational Health & Safety, or a related field; or equivalent relevant work experience. 
• 10+ years of experience in facilities management and/or maintenance operations, with required EHS leadership experience in manufacturing, preferably within a regulated industry such as medical devices, pharmaceuticals, biotechnology, or related life sciences. 
• Strong knowledge of OSHA, EPA, and state/local regulatory requirements; experience with hazardous waste management, chemical handling, and emergency response; familiarity with medical device manufacturing environments including cleanrooms and sterile processing; ability to conduct risk assessments, job hazard analyses, and ergonomic evaluations; experience supporting FDA, ISO 13485, and GMP compliance; ability to lead incident investigations and implement corrective and preventive actions; and understanding of industrial hygiene principles, exposure monitoring, and control strategies. 
• Strong communication abilities; leadership presence; excellent problem‑solving and analytical thinking; high attention to detail; strong organizational skills; ability to follow instructions and manage multiple priorities; and a team‑oriented, continuous‑improvement mindset. 
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook); experience with EHS and facilities management systems such as incident tracking, CMMS, training platforms, and SDS databases; and the ability to interpret digital dashboards, metrics, and reporting tools. 
• Physical requirements include the ability to lift up to 10–25 pounds occasionally; stand, walk, or sit for extended periods (up to 8 hours/day); work in manufacturing and cleanroom environments while wearing required PPE; respond to emergencies including spill response and alarm situations; and work safely around chemicals, equipment, and other typical manufacturing hazards with appropriate protective equipment. 
• Work location: Pleasanton, CA (onsite) 
• Travel: <5% 
• Full time employment 
• Compliance with relevant county, state, and Federal rules regarding vaccinations. 

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive salary offering a generous annual base range between $220,000 and $240,000 and variable incentive plan 
• Stock options—ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off